Food Plant Sanitation and Safety Challenges in Nigeria

DESIGN, PROCESS AND CONTROL OF READY-TO-EAT (RTE’s) FOOD MANUFACTURING FACILITIES IN NIGERIA: OVERVIEW OF GOOD MANUFACTURING PRACTICES (GMPs) AND STANDARD OPERATING PROCEDURES FOR NIGERIAN FOOD INDUSTRY. DEVELOPMENT OF RTE’s FOOD PRODUCTS IN NIGERIA Nigerian Food Industry still under developed is moving steadily in the African markets with a projected turnover of $40.6bn in 2020, The growth year-on-year for the industry in 2016 is projected at 10.5% CAGR during next 4-5years to become home of African food manufacturers with massive international and local investment shifting their attention to Africa’s Second largest economy. The sector-wise break-up of Food Industry in Nigeria shows that Processed foods were most consumed taking a lion share of 37.6%, followed by Protein 32.3% and cereals 30%. Nigeria Food Industry has expanded at an unparalleled growth rate over the last five decades. The market for processed foods has shown both multi-nationals and indigenous food processing companies and fast food companies competing for unprecedented market share in Nigeria worth USD 2billion in FY’ 2015. Growing at a compound annual growth rate (CAGR) from 2015-2020 at +11.5 per cent annually, while the USD term is valued at +4.7 percent (BMI), the Nigerian processed foods industry is likely to touch USD 5billion in 2020 with Nigerian diversification into Agricultural sector after several years of being oil-dependent nation. With ever increasing demand for processed and packaged foods in the urban centres of Nigeria, rapid urbanization and economic growth, ever-expanding middle-class population and widen market structure that cuts across West Africa, has made food processing plants more viable in Nigeria. This is reflected in urban resident consumption of 72% of processed and packaged foods in 2015, while rural resident consumption is 28%. With growth of grocery retail industry and food service fueling consumption of processed foods. Processed and Packaged foods includes ready-to-eat foods, snacks foods, healthy and functional foods. The Processed food industry has been dominated by ready to eat market. According to a recent study, the Nigerian Ready-to-eat food market is expected to grow to $500.7mn by 2016 from the current level of $102.3mn (2012-2013). In Nigeria RTE food market, preservative, aseptic pouches and canned segment are more popular contributing approximately 95% of market share and the CAGR is growing at 70% derivative. RTE foods with longer shelving Food products without no refrigeration contribute 65% approximately of the total market. Ready-to-eat foods (RTE) are convenience foods, enclosed in aluminum container either aseptic pouches or canned foil that only need to be cut open, consumed cold or reheated before being served. RTE foods includes range of products viz. vegetarian/nonvegetarian meals, basic food and delectable deserts. These may be canned or Pouched

foods. They are many varieties but classified into two: Meals, Ready-to-eat (MREs), and direct, Ready-to-eat (RTEs) “Meal, Ready-to-Eat (MRE) Products are meals containing quick-serve, precooked components which can be consumed in an austere environment. Components are acceptable eaten hot or cold. There is no preparation required except to add water to the beverage items. Packaging is lightweight and suitable for use without mess gear. MRE is "thermostabilized," refrigeration is not required, as they are processed with High Pressure Processing (HPP) which is a non-thermal food process technology that allows for ready-to-eat (RTE) meals made with meat, seafood, fish, vegetables or carbohydrates to obtain longer and safer shelf-life while preserving the homemade taste and avoiding overcooking.’’

“Ready-to-Eat (RTE) Products are perishable refrigerated/frozen items such as luncheon meats, frankfurters, cooked patties and other fully cooked products and meals that do not require further heating before consumption. Therefore, it is important that appropriate heat treatments are applied and that all possible steps are taken to reduce potential contamination after the heat treatment or postprocessing.” Among pouched foods Ready To Eat (RTE) are flexible pouches either retort or High Pressure Processing (HPP) which has gained momentum having longer shelf-life and storage stability, cost effective, requires less processing time and retention of maximum nutrients compared to other storage materials. Retort or HPP pouch is a resistant bag made of laminated plastic film or foil. It is capable of being suppressed to high pressure (non-thermal treatment) or heat (thermal treatment) during food processing. This processes include pasteurization in High Pressure Processing (HPP), sterilization in canning etc. while sterilization is carried out in auto-clave, Pasteurization is done on HPP machine. Retort or HPP pouch generally consist of outer layer of polyester or nylon for printability and toughness, a middle aluminium foil layer that functions as the principal oxygen and water vapour barrier and an inner heat sealed polypropylene. Foods are first sealed and later treated under intense heat or pressure to kill harmful bacteria to ensure freshness and long shelf-life and storage stability. Products can be stored in ambient temperature with shelf life of 18 months or more without use of preservative. The most Critical Operations in Food manufacturing is the processing of RTE products. The production of RTE products, specifically the ones that have long shelf-stable and storage stability involve complex and demanding processes to prevent the products contamination and require a great amount or resources. The inherent risk of microbiological contamination associated with RTE operations is critical because it has a direct relations with human health after consumption. The difficulty in detecting contamination makes the outcome of these processes less predictable naturally having higher risk and being more difficult to control and mange.

Today, consumers demands more than the production of safe and shelf-stable foods and insist on high quality RTE foods with convenient end use. High temperature-short time (HTST) and ultra-high temperature (UHT) techniques have been developed to minimize the severity of heat treatment and promote product quality. Aseptic processing and packaging further minimize the heat severity by quick heating and cooling of the food under aseptic conditions prior to packaging.

HISTORY OF FOOD PROCESSING IN NIGERIA The availability of raw materials from the farms to factories for processing by the Nigerian food industries which are mainly agricultural goods, from semi-processed to finished products have foster the growth of many multinational such as Nestle, Flour mills, PZ Wilmar, May &baker, Unilever, Promassidor, Coca-Cola Hellenic etc. while the Nigeria’s indigenous food companies such as Dangote, Nigerian Breweries, Chi, Nigerian Distilleries, Aace Food Processing developing faster into multi nationals diversifying into beverages, edible oils, sugars and other sweeteners, drinks (alcoholic and non-alcoholic), fish and meat products sectors, emerging and developing market share in the Africa’s second largest economy. Though, Food manufacturing and processing as an industry was introduced into Nigeria by the United African Company (UAC) in 1923. Today, food industries in the country are so many that they are sub-divided into thirteen (13) categories. These are flour and grain; soft drinks and carbonated water; breweries; starch and miscellaneous food products; meat, poultry and fish; tea, coffee and other beverages; fruit juices, animal feed,

sugar; distilleries and blending of spirits; cocoa, chocolates and sugar confectioneries; agricultural and food chemicals and industrial packaging. Food processing projects involve the processing and packaging of meat products, fish and shell fish, dairy products, fruits and vegetables, grains and beverages production. It includes refinement, preservation, and improvement of product; storage, handling, packaging and canning. The processing may involve receiving and storing raw or partially processed plant, animal or other food materials, processing the raw materials into finished products, and packaging and storing the finished products. However, it is sad to note that the Current Good manufacturing practices and Standard Operating Procedures conditions in major food processing plant Small, Medium and even some large multi-nationals food processing plants with no sanitation practices in Nigeria is unsatisfactorily, which demands considerable and urgent attention for improvement evolving into sub-standard, poor quality food products. Plant Sanitation, Food Safety and Quality should be a major motivating factor during the design, construction and operation of any Food industrial set up with a consideration to Industrial waste as a major source of environmental pollution. The concept of Quality by Design is discussed in the FDA’s Guidance for food Industry:

“Quality cannot be tested into products; it should be built-in foods or should be by food-design.” Food, which is basic necessity of life, derives its importance from the fact that it stimulates the appetite, and supplies a variety of ingredients that give energy (carbohydrates, fat, dietary fiber); replace worn out tissues, thus promoting growth (protein); and help in preventing and curing diseases (vitamins and minerals). The concept of healthy eating for healthy living and longevity is not new. Apart from serving a biological need, food has become an economic and political weapon. Issues of food security and poverty have been recognized as necessary conditions for the creation of a stable socio-political environment for sustainable economic development. It is, therefore, not surprising that eradication of extreme poverty and hunger is one of the eight millennium development goals set to be achieved by 2020. Food meant for human and animal consumption should be produced under conditions of cleanliness and sanitary decency. No consumer would knowingly wish to consume food products that has been canned, dried or processed in a rodent infested, insect ridden, filthy or bacteriologically unclean factory. One of the primary objectives of any food processing plant is to make food product wholesome, clean and safe for human consumption at an affordable price.

Producers of ready-to-eat (RTE’s) food products in Nigeria need to have a deep knowledge of what underlies this type of manufacturing of food, such as the strict and extended regulations applicable and the cost of what is necessary to start and maintain these types of processes and productions. The EU GMP Annex 1 reinforces this idea referring that: “Sole reliance for RTE food product or other quality aspects of it must not be placed on any terminal process or finished product test”

Food Plant Managers and Processors of RTE’s product in Nigeria should understand the basic principles behind Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs) and Good Manufacturing Practices (GMPs) and how to comply with them when it comes to processing of RTE’s foods. Creating and complying with SOPs, SSOPs and GMP can be challenging for such food processors, but an understanding of similarities and differences between SSOPs and GMPs which sometimes

may seem difficult to plant manager and processors in regulatory viewpoint, but simpler in a coordinated, seamless factory operations viewpoint . Adequate facilities, equipment, materials, procedures, personnel, and a strong robust quality assurance policy are examples of these requirements to understand the importance of developing and implementing procedures to reduce the potential for contamination with microorganisms such as (yeasts, moulds, lactic acid bacteria, psycrotrophic bacteria) and pathogens(E.coli, Listeria, Salmonella, Cryptosporidium…). Therefore, it is extremely important that manufacturers of RTE’s products develop and implement effective Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) as the foundations of a successful HACCP program. Combining strong GMPs, SOPs, SSOPs and HACCP will increase the total process control system and help these manufacturers continue to produce the safest products possible. The development and successful implementation of these programs requires full management support and commitment. It should be noted that each RTE processor must validate the production process for these products as part of the HACCP development and implementation. Validation will ensure that the production process operated within established parameters would perform effectively and efficiently, reproducibly to produce a RTE product meeting its predetermined specifications and quality attributes which is adequate to control and eliminate all harmful microorganisms. All of these actions will help manufacturers of RTE products produce the safest RTE products possible. (Annex 15 of the EU Guide to GMP) In this article, we focuses our attention on the right structures (i.e. facility, personnel and processing) and also the production systems for developing GMPs and SOPs for RTE operations in Nigeria. It serves as a guideline for developing plant specific GMPs and SOPs conformances, while it addresses the issues of lotting, reprocessing in the production system with its recommendations focusing solely on the RTE products. It is important to note that the required structure and facilities for RTE’s Operations are addressed in detail in this document, but are covered by existing Sanitation Standard Operating Procedures (SSOPs) or other plant-specific processing programs: Personnel

- disease control, hygiene, clothing, training, etc.: Regardless of type of processing or food handling operation in ready-to-eat food, the number one consideration in food sanitation is people. It is people who set the rules, follow the rules, and also break the rules of sanitation. A sanitation program is as good as the attitude, willingness, and efforts of people. That is why the most important aspect of a sanitation program is ongoing personnel training Personnel training should include appropriate sanitation principles and food handling practices, manufacturing controls, and personal hygiene practices, etc. as stated below:

 Sanitation Principles and Food Handling Practices: Personnel training should instill and nurture an understanding of the processing steps and technologies for each product manufactured or handled and where potential problems exist, and create a keen desire to satisfy and guard the consumers’ interests.  Manufacturing Controls and Essential Operations: Production personnel must be trained in the critical elements of the operations for which they are responsible, in the importance of these operations, monitoring these operations, and in action to be taken when these operations are not controlled. Certain industries have developed certification programs for operators of essential heat-processing equipment (e.g. milk pasteurizer or retort operators). If such programs don’t exist for a given processing segment, it is important that specific training programs be developed for such personnel in RTE Food Industries in Nigeria.  Hygienic Practices, Communicable Diseases/Injuries: Persons known to be suffering from, or known to be carriers of a disease likely to be transmitted through food, must be restricted from any food-handling area. Likewise, persons afflicted with infected wounds, skin infections, sores, etc., must also be restricted from these areas. Any persons with open cuts or wounds should not handle food unless the injury is completely protected by a secure, waterproof covering.  Hand-washing: Facilities with hot water for hand-washing must be provided and must be convenient to food handling areas. All personnel involved in food handling must thoroughly wash hands with warm-running potable water using hand washing stations with soap and sanitizer (i.e. 3050 ppm chlorine solution). Hands must also be washed after handling contaminated materials and after using toilet facilities. Where required, employees must use disinfectant hand dips.  Traffic Control/Controlled Access: Personnel and visitor access to ready-to-eat food- product handling areas must be restricted. Personnel involved in raw product handling (e.g., farm truck drivers, etc.) must not be allowed in processing or finished product areas. Foot baths and hand dips, where required, must be properly maintained and used. Color coding of clothing, maintenance and other equipment should be used to clearly identify raw vs. processed product operations.  Personal Cleanliness and Conduct: Personal cleanliness must be maintained while involved in ready –to-eat food handling operations: • Sanitary protective clothing, hair covering, and footwear must be worn and maintained in a clean, sanitary manner. • Gloves, if worn, must be clean and sanitary. • All food-handling personnel must remove objects (i.e.watches, jewelry) from their person which may fall into or contaminate the food product.

• Tobacco, gum, and food are not permitted in food handling areas. Plant

and grounds - construction and design, product flow, drainage, etc.:  Building Construction: The facility should have floors, walls, and ceilings constructed of suitable, approved materials which are durable, smooth, impervious and easily cleaned. Walls should be light colored and welljoined, and floors should be adequately sloped for drainage to trapped outlets. Openings to outside and/or non-food-processing or -handling rooms or facilities must be sealed. Instrument panels should be appropriately locked and sealed to prevent harborage of insects. Windows and doors must be tight and close-fitting. And doors in

food-processing areas self-closing. Overhead structures should be situated and constructed to prevent contamination of the food products, and lighting is to be adequate with properly sealed, safety type overhead fixtures.  Product Flow-through Pattern: A well-designed food-processing or handling facility is constructed to minimize traffic to prevent contamination. It is desirable to have a product flow-through that physically and operationally separates raw product functions from processing functions and finished product functions in order to avoid crosscontamination. Boiler and engineering rooms must always be separated from food-processing and -handling areas.

Sanitary

operations – general sanitary design and maintenance, cleaning and sanitizing, pest control, etc.:  General Sanitary Design: The overall requirement for design of equipment for food processing and -handling operations is that it be cleanable and maintained in such a manner as to prevent contamination. Food-contact surface equipment standards-of varying thoroughness- have been developed for segments of the food industry.  Equipment Calibration and Maintenance/Preventive Maintenance: A sanitary operations facility has a preventive maintenance program which monitors equipment maintenance procedures. Such a program specifies necessary servicing intervals, replacement parts, etc.  Cleaning and Sanitizing Equipment: Thoroughly evaluate the effectiveness of cleaning and sanitizing programs. Use of color-coded cleaning utensils for different sections of the plant, while brushes must be used appropriately to clean food contact surfaces. If you use cloths to wipe food contact surfaces, dip the cloth in sanitized water between uses. Consulting a reputable cleaning and sanitizing supplier and follow

recommended procedures for cleaning and sanitizing both food- product contact and non-product contact surfaces in specific operations.  Pest Control: Basic pest control involves elimination of pest harborage areas and prevention of entry to the new building. This is accomplished by an integration of several design steps. Landscaping design need not be spartan, but can provide aesthetic appearance while preventing pest harborage and access. Grass and shrubbery is kept trimmed and away from the plant to supplement pest control. A 30-36" wide and 4" deep strip of pebbles around the building eliminates areas of pest harborage and hidden runway for rodents. This also provides easy access to perimeter bait stations for pest control operators. Exclusion of pests is accomplished through adequate door seals, as well as screening of doors and windows with 22-mesh or finer material. Use of air curtains on doors that open to the outside provides extra protection against pest entry. Placement of external lighting in locations away from the building will illuminate entrances, but not attract insects to the building. Use of insect electrocutors inside the building will attract and catch flying insects that may happen to enter the facility. The types of electrocutors with blue lightning, designed to attract insects due to the light wavelength, are best placed away from doors and windows so that they will not attract insects into the building from the outside. Of course, these are not to be placed over or near areas where food or ingredients are stored, because the process of electrocution often causes the insect body to explode.

Sanitary

and offal

facilities and controls - water supply, plumbing, sewage disposal, rubbish disposal, etc.

 Water Supply, plumbing and sewage disposal: All plumbing, airlines, ducting and electrical conduit travel through a structural ceiling loft. There are no sewage lines running over production or storage areas, rather they have been directed to non-production areas. Making sure that the plumbing does not create any dead-end connections and all potable water lines for processing and sanitation have back-flow prevention devices. Ducting in the loft is round to minimize flat surfaces that can collect dust. There are no exposed overhead pipes or conduit supported by angle iron, unistrut or all thread, because these materials create flat surfaces that can collect dust and plant soil. I have used only smooth hanger rods. Lights are recessed and shielded to prevent a glass contamination hazard and provide sufficient illumination to allow for inspection of equipment and associate work tasks. The ceiling is made of insulated FRP to maintain plant temperatures and to aid in cleaning and condensation control. I have avoided the use of a track-andgrid system with ceiling tiles, since this is not easily cleaned or sealed.

Freezers

and coolers - monitored and maintained to ensure temperature control, recording devices, alarms, etc.  Temperature Control: The primary rule of sanitation is to pay strict attention to food temperatures in RTE’s foods, this include: • Avoid prolonged holding in the danger zone (from 40°F to 140°F). • Provide functional thermometers to all food storage boxes. • Monitor the temperature on serving lines on a regular frequency. Equipment

maintenance and calibration - adequate frequency for thermometers, recording devices, compressed air equipment, etc.  Equipment Calibration: Protocols and calibration methods must be established for all equipment that could impact on food safety. These include: thermometers, pH meters, water activity meters, refrigeration controls, scales, recording thermometers, hygrometers, and other equipment. All reagents used for monitoring and verification must be documented and stored properly, appropriate monitors must be used. Recall program - It is recommended that all RTE’s facilities develop a recall program and that mock recalls should be conducted periodically to ensure that the program works as planned.

 Recall Program: An important part of food sanitation program is having a working product-recall system in place. The recall program establishes procedures to be implemented in the event of a product recall. Written recall procedures should be established and tested for validity.

For an effective RTE facility operations in Nigeria, Each RTE’s facility should have a lotting mechanism for coding or recording finished products to allow tracing the product back through the system and for tracing the product forward through the chain. Some RTE’s establishments may develop computerized bar codes or tracking systems that are very elaborate and detailed, and others may have simple handwritten documentation and box/package codes.

Lotting is driven by some time factor (i.e., hour, shift, day, etc.) and is given a specific code. Creating smaller lots or utilizing a sub-lotting system for tracking information may help demonstrate/document process control and could possibly help to minimize the economic impact of recalls. Regardless of the mechanism used in each RTE facility operations, a good facility should have a good record keeping system, which must be able to provide the following items as listed below for documentation in sub-lot/lot identification: ¨ Raw material source(s) by vendor, including vendor lot identification ¨ Equipment evaluation records (i.e., maintenance records) ¨ Data collected during processing operations (temperatures, microbial data, etc.) ¨ Other items as specified and requested by individual customer that would meet customer services satisfaction. In the case of any abnormal indicator found during the process operations, segregation of the product should be the first operation, followed by cleaning and sanitizing of the processing line as this must be completed prior to reinitiating production, while a new lot/sub-lot is started all over again when production starts back up. Some operations require implementing a sub lotting system that requires the under listed documentation: Batching records — These records identify the types of raw material used in the production by tracking codes; the amount used in each batch of formulated product, the time it was used and the locations of equipment it was used on. ¨

Packaged product tracking systems — Finished products should be coded with the actual times they are packed and sealed and pallets of products should contain consecutive products off the line. Packaging systems with multiple lines should have a consistent flow of raw materials to each packaging line and the ability to code and identify products from a specific line as necessary. ¨

Downtime tracking sheets can be used to identify lines that were not packaging products at the time of suspect incidents and therefore created a break in the flow of products through the system. ¨Finished

Product “On-Hold” Programs — In testing a finished RTE products for potential microbial adulterants, then it should require appropriate product/lot(s) to be held until laboratory testing is completed and the results are made available. Records for operations should include the total amount of products produced as well as their location. However, it should be noted that end-product test and hold programs are not generally recommended.

Another critical aspect in the production system of RTE’s product is “REPROCESSING”.

Reprocessing occurs when allowing products that do not meet the company specifications or non-confirmity (broken, ends and pieces, leakers, etc.) to reenter the system. It is an important factor that is considered in RTE production system. Hence with regards to reprocessing of RTE’s products, the following categories are recommended to help distinguish between the types of reprocessing activities that may occur during the production of RTE products. 1. Retreatment— Allows products that have received/undergone heat/pressure treatment but do not meet the operational specifications to go through the heat/pressure treatment again. These products may be reheated/undergo high pressure processing if the product allows it or they may be reintroduced into the production system within the acceptable stipulated regulations of NAFDAC guidelines. Such items include: 

RTE’s product that do not meet “production specifications or nonconfirmity” (i.e., mis-sliced, broken, ends and pieces, leakers, pinholes, products that do not meet the sensory evaluation, etc.)



Products that do not meet the CCP for heat treatment.



Products that do not meet the cooling requirements.

2. Repackaging — Allows product that has received the heat/pressure treatment but does not meet the operational specifications (leakers, coding, film, labels, etc.) to be repackaged without receiving an additional heat/pressure treatment. These products must still be within the post-heat/pressure treatment processing area (i.e., processing room, chiller, and packaging room). After products leave the post-heat/pressure treatment production environment (cooling room), the products should not be allowed to be repackaged and must re-enter via recooking as described above. 3. Returned and reinspected product — RTE products that are returned not be repackaged or redistributed, until the establishment can evaluate and document the safety of the product handling since it left the facility and the product integrity has been maintained. For example, if product was inadvertently loaded onto a truck and remained on the truck throughout the delivery route at an appropriate temperature and was then returned at the end of the delivery, then the establishment may allow this product to be returned to available inventory.

*Note*: Unprotected RTE products that fall onto the floor must be discarded. They cannot be reprocessed and/or reconditioned to reenter the food supply.

GOOD MANUFACTURING PRACTICES (GMPs) FOR RTE’s FOOD PRODUCTS IN NIGERIA Good Manufacturing Practices (GMPs) contain both requirements and guidelines for manufacturing of food and drug products in a sanitary environment. In Nigeria, the standard Organization of Nigeria (SON) has been working hand-in-hand with National Agency for Food, Drug Administration and Control (NAFDAC) in developing and delivering Good Manufacturing Practices for all food processes and Products in Nigeria most especially Ready-to-eat because . Both statutory agencies had enforces strict compliance on GMPs for all foods products exported and produced within Nigeria territory. “Good Manufacturing Practices (GMPs) as defined by the Food and Drug Administration in 21 CFR part 110 are the minimum sanitary and processing requirements to ensure the production of wholesome food by food companies. GMP regulations are designed to control the risk of contaminating foods with filth, chemicals, microbes, and other means during their manufacture’’

An estimated 2 million cases of foodborne illness occur annually in Nigeria. A large majority of these result from poor hygiene practices and Sanitation. For example, it has been documented that between 30% and 70% percent of persons do not wash their hands after using the restroom. Proper training of employees is the primary means to reduce food contamination in any RTE’s processing plant.

GMPs are fairly broad and general, and can be used to help guide the development of Standard Operating Procedures (SOPs) which are very specific. Recommended guidelines for developing Good Manufacturing Practices for RTE’s operations in Nigeria’s Food Industry are for voluntary consideration and use in developing plantspecific procedures.

These GMPs are not designed to control specific hazards, but are intended to provide guidelines to help food processors’ produce safe and wholesome products. The general guidelines in achieving the best practices in GMP operations in any RTEs facility in Nigeria can be summarized into two sections: Pre-Processing and PostProcessing handling. Pre- Processing handling In RTE Production, Pre- Processing handling is a critical stage which requires evaluation and assessment of raw materials products that would be used in the manufacturing process from vendor or suppliers to ensure strictly conformance based on specifications, quality and standard requirements and must satisfactorily meets all these requirement. Pre-processing handling includes Receiving/incurring test and inspection, In-process inspection, Laboratory acceptance testing. Etc. Receiving Meat Items or Ingredients Incoming meat ingredients to be used in RTE production should be evaluated to ensure that it meets the plant-established purchase specifications.

Trucks, containers and carriers of raw materials should be evaluated upon receipt to ensure that the conditions meet plant requirements for transporting meat. All incoming meat should be coded/identified for plant use and for the in-plant tracking system. Non-Meat Items or Ingredients Producers of RTE products need to make sure that all non-meat items/ingredients, such as packaging materials, seasonings/spices, etc. meet the plant-established specifications. In Nigeria, NAFDAC currently requires companies to have a Letter of Guarantee (LOG) from suppliers of non-meat ingredients relating to the use of food grade substances, foreign materials, pest control programs, etc. After the company accepts the non-meat items, then these items should be stored, handled and used in a manner that will maintain the integrity of the items. Storage of Raw Materials Raw materials used in any RTE food processing plant must be based on a First-In/FirstOut (FIFO), basically according each plant should have a specified product rotation/inventory control schedule, such as the oldest bone date.

Raw materials/Ingredients should be stored at temperatures that maintain proper product condition. Frozen materials should be kept frozen, unless tempering or thawing is required prior to use. The package/pallet integrity must be maintained throughout the storage period to maintain the condition of the material. Product identity in storage should allow for the in-plant tracking system. Tempering/Thawing of Frozen Materials Tempering or thawing of frozen material prior to use, should be done in a time/temperature controlled manner, which must be adequately monitored and documented for record purposes. A Product package integrity is important during this process. Product’s traceability should be maintained throughout the tempering/thawing process for easy accessibility in case of product recall due to cross-contamination. Processing Processing includes the application of thermal (heat) and non-thermal (Pressure) treatment directly or indirectly to the RTEs food product, but is not limited to — weighing, mixing, blending, grinding, forming, stuffing, or other activities conducted prior to applying the thermal/non-thermal treatment on food processes. An evaluation of organoleptic properties of the raw material ingredients must be completed prior to adding the meat items/ingredients to any batch of finished products. All the ingredients should be evaluated for chemical composition (% fat and lean) to formulate product to desired endpoint. All procedures in ensuring proper end product characteristics (i.e., quantity, physical characteristics, weights etc.) must be in place. In-plant tracking mechanism and traceability should allow for batch identification and time of batch production, and even sublot identification of each batch in a cooking lot if applicable to the processing system.

Any RTEs facility/establishment in Nigeria should have a validated HACCP programs and that must include appropriate controls for identifying hazards throughout the processing system.

Post-Processing Handling It is however important, that RTE producers must recognize the importance of preventing cross contamination of post-processed even after applying thermal/nonthermal treatment on products with raw materials such example of such treatment is “sterilization/pasteurization method”. This type of operations should have process control mechanisms to prevent cross contamination.

There are four essential factors noted which can impact on the established controls of Post-Processing handling: 1. Facility Design and Production Flow: An optimal facility design provides flow of operations in a food processing facility that would completely separate raw and cooked processing areas. Most RTE manufacturing processes are performed in “Clean Room”. A clean room can be defined as a room in which the concentration of airborne particles and other environmental conditions, such as temperature, humidity, and pressure, are controlled. This type of environment is a requirement for the manufacturing of RTE products in order to minimize the risk of biological, physical, and chemical contamination hazard. The air handling and the type of surface materials are examples of important issues to be dealt with in the construction of a cleanroom in line with construction requirements provided by NAFDAC or any Nigerian Statutory agencies. The necessary space must be available in cleanrooms so all the operations and procedures can be performed properly. Equipment and other items introduced in cleanrooms should be considered since they can influence the cleanroom’s performance. The air that enters the cleanroom has to be filtered by an adequate High Efficiency Particulate Air (HEPA) filter, in order to prevent contaminations from the outside. The number of air changes has to be adequate to dilute contamination generated from the process; equipment and personnel and airflow patterns inside the clean areas must prevent the contamination of the critical areas, where RTE products and other important items are manipulated. The pressure differentials inside the RTE facility must prevent airflows from less clean areas to clean areas. When dealing with potent parenteral products, the pressurization scheme also must address containment issues. Cleanrooms can be divided in four types, according to the airflow pattern: •

Conventional: Conventional cleanrooms are the ones that present less protection for the product, as the critical areas also are not segregated from other areas and the flow inside the room is turbulent.

•

Unidirectional Flow: Unidirectional flow cleanrooms are completely covered by unidirectional flow. In this case, the critical areas are not segregated from other areas.

•

•

Mixed Flow: Mixed flow is considered the basic design concept for a cleanroom with a unidirectional flow inside a conventional room with turbulent flow. In this case, the critical areas are not as protected as the previous situations. Isolators, RABS, or Microenvironments: Isolators, RABS (open or closed), or microenvironments are the ones that offer better processing conditions since access to the critical area is very limited. These critical areas, where RTE product materials are exposed, are completely segregated and protected by unidirectional flow.

In situations where RTE products is less protected, very well defined procedures are required to prevent contamination.

CLEAN ROOM CLASSIFICATION Regulatory documents and norms define tests and specifications to demonstrate the compliance of the cleanroom to certain cleanliness classes. For example, EU and FDA GMPs refer to ISO Standards in what concerns detailed methods for classification of cleanrooms. Parameters that must be evaluated when testing a clean room involve: • • • • • •

Leak tests to the HEPA filters Number of particles Air change rates Recovery times of the cleanroom after a contamination event airflow patterns pressure differentials

Specific controls that may be addressed in the Clean Room design/SOPs include: • • • • • • •

Use of footbaths before entrance into a RTE area, including preparation of sanitizing agent, schedule for changing, etc. Physical barrier (preferably from floor to ceiling) for separating raw and cooked processing areas Positive air flow in exposed product packaging rooms Employee traffic flow to prevent cross-over between raw and cooked areas Separate frocks and colored-coded utensils for different section of plants etc. Proper design, use and cleaning of drains Designated equipment and tools for RTE when possible.

At times due to plant design, a physical barrier may not provide complete separation, then additional steps should be taken to help minimize the risk of contaminating post-processing products. For example, in such an establishment with only one packaging room which both serve raw and RTE

Products, its best advice sable to designate separate “processing times” should be introduced. In such operations, RTE products should be packaged first while the room is clean, and then the raw products could be packaged later. This “separation” allows using process schedules to prevent cross contamination.

While it is important noting that all of the other facility control steps should be addressed even if scheduling processing times is used as the method for providing “physical separation.” *Note*: All RTE facility that is utilizing a processing schedule to provide the separation must have a strict sanitation program and a process for evaluating equipment prior to use. During plant tours all visitors must adhere strictly and follow plant hygiene requirements related to handwashing, dress, etc., while the tour flow must ensure that contamination of cooked with raw does not occur i.e. the first contact of visit should be the cooked processing areas before going to the raw product areas. 2.

Sanitation:

It is necessary for all food establishments to recognize the importance of the sanitation personnels and the activities performed and completed during the sanitation process in any food facility. Sanitation program must be effectively implemented and appropriate results obtained. It is recommended that producers of RTE products evaluate their Sanitation Standard Operating Procedures (SSOPs) to ensure that they are adequate and in line with international best practices. Sanitation programs should include: Management

commitment through active and continuous demonstration, including sufficient funding for personnel, equipment, training, and supplies. 

Written

procedures for completing the sanitation activities including the appropriate dress/personal hygiene issues for the personnels in the RTE areas. Suggest

use of separate cleaning crews and equipment as possible

Evaluation

of reporting structure for sanitation crew

Recommend

that the RTE rooms be first on the cleaning schedule to prevent contamination from previously cleaned rooms Method

to establish accountability for the sanitation programs which may include the use of: - Review of sanitation crew training records - Third-party audits of sanitation program. - Tracking of chemical usage, types, concentrations and rotation schedules - Review of Non-compliance Records (NRs) related to sanitation with the sanitation crew and other appropriate personnel. - Microbiological monitoring - Coliform plates - Standard plate counts - Environmental testing for Listeria species - Pre-operational ATP testing - Visual inspections (organoleptic evaluation)

Facilities should establish a mechanism for tracking sanitation issues to provide a systematic evaluation of the operating sanitation conditions of the RTE room. Examples of these issues include: Room

temperatures Build-up on equipment Debris collection Standing water and condensation removal Use of hoses (Recommend that the use of hoses be restricted during operation/processing of RTE products.) Cleaning/sanitation schedule for personnel contact surfaces that are not cleaned/sanitized on a routine basis (i.e. control panels, switches, etc.)

3. Material handling: Procedures should be established for material handling in order to help prevent cross contamination of post-processed RTE products. Material handling practices that should be consider for development in the RTE establishment include: Procedures that would; Develop Material flow to prevent raw to cook contamination.  Ensure proper labeling of ingredients/products.

Payspecial

attention to the handling of packaging materials that remain in the room at the end of the day and how such packaging material are removed during cleaning of the room.  Address the cleaning and sanitizing pallets, containers, trashcans, etc. before entering the RTE processing area and also outer package surface to prevent post-processing contamination. (sanitizing casing dip before removal, inner cook bag)  Prevent contamination of RTE packaging materials. Address condition and flow, if conveyors are used in the process due to difficulty of cleaning and sanitizing conveyors belts. Control RTE processing areas in addressing condition, number and time within the area, also allowed minimum number of transfer product to be stacked/stored in RTE processing areas, if wooden pallets are used. *Note*: All unprotected RTE products that falls on the Processing/Production floor ground during processing should be discarded. Such Products should not be reprocessed for reconditioning into the processing food supply. Storage of Finished RTE Product: Essential care should be taken to ensure Finished RTE products should be handled in a method that provides separation of raw and cooked products. Plantdesignated time and temperatures should be maintain to maximum capacity inorder to protect product shelf-life and storage stability. All Frozen products should be kept frozen at its required temperature. Plant specified or first-In-first- Out method product rotation and inventory control schedule should be maintained for all RTE finished products. Finished Product package and pallet integrity should be maintained throughout the storage period to preserve product condition and shelf-life.